Prosthetic heart valve delivery system with controlled expansion

ABSTRACT

A system for repairing a defective heart valve. The system includes a delivery device, a balloon and a prosthetic heart valve. The delivery device includes an inner shaft assembly and a delivery sheath assembly. The delivery sheath assembly provides a capsule terminating at a distal end. The prosthesis includes a stent carrying a prosthetic valve. In a delivery state, the capsule maintains the prosthesis in a collapsed condition over the inner shaft assembly, and the balloon is in a deflated arrangement radially between the prosthetic heart valve and the capsule. In a deployment state, at least a portion of the balloon and at least a portion of the prosthetic heart valve are distal the capsule. Further, the balloon is inflated and surrounds an exterior of at least a portion of the prosthetic heart valve. The balloon controls self-expansion of the prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.15/369,154, filed Dec. 5, 2016, entitled “Prosthetic Heart ValveDelivery System with Controlled Expansion,” the entire teachings ofwhich are incorporated herein by reference.

BACKGROUND

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrio-ventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Diseased or otherwise deficient heart valves can be repaired or replacedusing a variety of different types of heart valve surgeries. Oneconventional technique involves an open-heart surgical approach that isconducted under general anesthesia, during which the heart is stoppedand blood flow is controlled by a heart-lung bypass machine.

More recently, minimally invasive approaches have been developed tofacilitate catheter-based implantation of the valve prosthesis on thebeating heart, intending to obviate the need for the use of classicalsternotomy and cardiopulmonary bypass. In general terms, an expandableprosthetic valve is compressed about or within a catheter, insertedinside a body lumen of the patient, such as the femoral artery, anddelivered to a desired location in the heart.

The heart valve prosthesis employed with catheter-based, ortranscatheter, procedures generally includes an expandable multi-levelframe or stent that supports a valve structure having a plurality ofleaflets. The frame can be contracted during percutaneous transluminaldelivery, and expanded upon deployment at or within the native valve.With one type of stented prosthetic heart valve design, the stent frameis formed to be self-expanding. The valved stent is crimped down to adesired size and held in that compressed state within a sheath fortransluminal delivery. Retracting the sheath from this valved stentallows the stent to self-expand to a larger diameter, fixating at thenative valve site. In more general terms, then, once the prostheticvalve is positioned at the treatment site, for instance within anincompetent native valve, the stent frame structure may be expanded tohold the prosthetic valve firmly in place. One example of a stentedprosthetic valve is disclosed in U.S. Pat. No. 5,957,949 to Leonhardt etal., which is incorporated by reference herein in its entirety.

The stent frame must oftentimes provide and maintain (e.g., elevatedhoop strength and resistance to radially compressive forces) arelatively complex shape in order to achieve desired fixation with thecorresponding native anatomy. When forcibly compressed within an outersheath to a size or diameter appropriate for transluminal delivery, theself-expanding stent frame thus stores significant energy. Uponretraction of the outer sheath, this stored energy is released as thestent frame rapidly self-expands, applying a high radial force on tonative anatomy. Rapid release or expansion may be undesirable, possiblycausing trauma, reshaping, etc., of the native anatomy.

SUMMARY

The inventors of the present disclosure recognized that a need existsfor transcatheter heart valve repair systems that overcome one or moreof the above-mentioned problems.

Some aspects of the present disclosure are directed toward a system forrepairing a defective heart valve of a patient. The system includes adelivery device, a balloon and a prosthetic heart valve. The deliverydevice includes an inner shaft assembly and a delivery sheath assembly.The delivery sheath assembly is slidably disposed over the inner shaftassembly, and provides a capsule terminating at a distal end. Theprosthetic heart valve includes a self-deploying stent carrying aprosthetic valve. The system is configured to provide at least adelivery state and an initial deployment state. In the delivery state,the capsule maintains the prosthetic heart valve in a collapsedcondition over the inner shaft assembly, and the balloon is in adeflated arrangement radially between the prosthetic heart valve and thecapsule. In the initial deployment state, at least a portion of theballoon and at least a portion of the prosthetic heart valve are locateddistal the distal end. Further, the balloon is in an inflatedarrangement and surrounds an exterior of at least a portion of theprosthetic heart valve otherwise exposed distal the capsule. With thisconstruction, the balloon slows or provides control over self-expansionof the prosthetic heart valve. In some embodiments, the balloon has aring or toroid shape. In some embodiments, the system is configured suchthat the balloon can be disconnected from a remainder of the deliverydevice following deployment of the prosthetic heart valve. In otherembodiments, the capsule forms an inflation lumen fluidly connected toan inflation chamber of the balloon.

Other aspects of the present disclosure are directed toward a method forrepairing a heart valve of a patient. The method includes manipulating aheart valve replacement system in a delivery state to deliver aprosthetic heart valve of the system to a target site. The systemfurther includes an inner shaft assembly, a delivery sheath assemblyproviding a capsule terminating at a distal end, and a balloon. Thedelivery state includes the capsule maintaining the prosthetic heartvalve in a collapsed condition over the inner shaft assembly, and theballoon in a deflated arrangement radially between the prosthetic heartvalve and the capsule. At least a portion of the balloon is exposeddistal the distal end of the capsule. The exposed portion of the balloonis inflated. At least a portion of the prosthetic heart valve ispositioned distal the distal end of the capsule. In this regard, theinflated balloon is disposed between the portion of the prosthetic heartvalve and anatomy of the target site. The prosthetic heart valve is thendeployed from the inner shaft assembly to the target site. In someembodiments, the method further includes disconnected the balloon from aremainder of the delivery site such that upon final deployment of theprosthetic heart valve, the balloon remains in place between theprosthetic heart valve and anatomy of the target site. In otherembodiments, the method further includes incrementally retracting thecapsule and balloon in tandem relative to the prosthetic heart valve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a stented prosthetic heart valve useful withsystems, devices and methods of the present disclosure and in a normal,expanded condition;

FIG. 1B is a side view of the prosthetic heart valve of FIG. 1A in acompressed condition;

FIG. 2 is a side view of another exemplary prosthetic heart valve stentuseful with systems, devices and methods of the present disclosure andin a normal, expanded condition;

FIG. 3 is an exploded perspective view of a prosthetic heart valvedelivery device in accordance with principles of the present disclosure;

FIG. 4A is a perspective view of a balloon useful with the deliverydevice of FIG. 3;

FIG. 4B is a longitudinal cross-sectional view of the balloon of FIG.4A;

FIG. 5A is a simplified cross-sectional view of the balloon of FIG. 4Aassociated with a prosthetic heart valve;

FIG. 5B is a simplified cross-sectional view of the arrangement of FIG.5A with the prosthetic heart valve in a collapsed condition;

FIG. 5C is a simplified cross-sectional view of the arrangement of FIG.5B with the balloon in an inflated arrangement;

FIG. 6 is a simplified cross-sectional view of a portion of a system inaccordance with principles of the present disclosure, including thedelivery device of FIG. 3 and a prosthetic heart valve;

FIGS. 7A-7D illustrate use of the system of FIG. 6 in repairing a heartvalve in accordance with methods of the present disclosure;

FIG. 8 is a cross-sectional view of a portion of another delivery devicein accordance with principles of the present disclosure;

FIG. 9A is a perspective, cross-sectional view of a portion of thedelivery device of FIG. 8, including a balloon and a capsule;

FIG. 9B is a longitudinal cross-sectional view of the portion of FIG.9A;

FIG. 10 is a longitudinal cross-sectional view of another system inaccordance with principles of the present disclosure, including thedelivery device of FIG. 6 and a prosthetic heart valve in simplifiedform; and

FIGS. 11A-11E illustrate use of the system of FIG. 10 in repairing aheart valve in accordance with methods of the present disclosure.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician. “Distal” or“distally” are a position distant from or in a direction away from theclinician. “Proximal” and “proximally” are a position near or in adirection toward the clinician. As used herein with reference to animplanted valve prosthesis, the terms “distal”, “outlet”, and “outflow”are understood to mean downstream to the direction of blood flow, andthe terms “proximal”, “inlet”, or “inflow” are understood to meanupstream to the direction of blood flow. In addition, as used herein,the terms “outward” or “outwardly” refer to a position radially awayfrom a longitudinal axis of a frame of the valve prosthesis and theterms “inward” or “inwardly” refer to a position radially toward alongitudinal axis of the frame of the valve prosthesis. As well theterms “backward” or “backwardly” refer to the relative transition from adownstream position to an upstream position and the terms “forward” or“forwardly” refer to the relative transition from an upstream positionto a downstream position.

Aspects of the present disclosure provide a system for performing atherapeutic procedure on a defective heart valve of a patient, such asrepairing a defective heart valve. The systems of the present disclosuregenerally include a prosthetic heart valve, a delivery device, and aballoon. The delivery device is configured to deliver the prostheticheart valve through a patient's vasculature and deploy the prostheticheart valve at a target site. The balloon assists in controllingdeployment. In some embodiments, the balloon remains at the target site,and can optionally be considered a component of the prosthetic heartvalve. In other embodiments, the balloon is removed from the target sitefollowing deployment of the prosthetic heart valve, and can optionallybe considered a component of the delivery device. As a point ofreference, “repairing” a defective heart valve is inclusive of theprosthetic heart valve implanted on to existing valve anatomy (e.g., thenative valve leaflets are not removed, but are rendered non-functionalby the implanted prosthetic heart valve), and is also inclusive ofremoving at least a portion of the native valve anatomy prior toimplanting the prosthetic heart valve.

As referred to herein, stented transcatheter prosthetic heart valvesuseful with and/or as part of the various systems, devices and methodsof the present disclosure may assume a wide variety of differentconfigurations, such as a bioprosthetic heart valve having tissueleaflets or a synthetic heart valve having polymeric, metallic ortissue-engineered leaflets, and can be specifically configured forreplacing any of the four valves of the human heart. Thus, the stentedprosthetic heart valve useful with the systems, devices, and methods ofthe present disclosure can be generally used for repair (e.g.,replacement) of a native aortic, mitral, pulmonic or tricuspid valve, orto repair (e.g., replace) a failed bioprosthesis, such as in the area ofan aortic valve or mitral valve, for example.

In general terms, the stented prosthetic heart valves of the presentdisclosure include a stent or stent frame having an internal lumenmaintaining a valve structure (tissue or synthetic), with the stentframe having a normal, expanded condition or arrangement and collapsibleto a compressed condition or arrangement for loading within a deliverydevice. The stent frame is normally constructed to self-deploy orself-expand when released from the delivery device. For example, thestents or stent frames are support structures that comprise a number ofstruts or wire segments arranged relative to each other to provide adesired compressibility and strength to the prosthetic heart valve. Thestruts or wire segments are arranged such that they are capable ofself-transitioning from a compressed or collapsed condition to a normal,radially expanded condition. The struts or wire segments can be formedfrom a shape memory material, such as a nickel titanium alloy (e.g.,Nitinol™). The stent frame can be laser-cut from a single piece ofmaterial, or can be assembled from a number of discrete components.

With the above understanding in mind, one simplified, non-limitingexample of a stented prosthetic heart valve 30 useful with systems,devices and methods of the present disclosure is illustrated in FIG. 1A.As a point of reference, the prosthetic heart valve 30 is shown in anormal or expanded condition in the view of FIG. 1A; FIG. 1B illustratesthe prosthetic heart valve in a compressed condition (e.g., whencompressively retained within an outer catheter or sheath as describedbelow). The prosthetic heart valve 30 includes a stent or stent frame 32and a valve structure 34. The stent frame 32 can assume any of the formsmentioned above, and is generally constructed so as to beself-expandable from the compressed condition (FIG. 1B) to the normal,expanded condition (FIG. 1A).

The valve structure 34 can assume a variety of forms, and can be formed,for example, from one or more biocompatible synthetic materials,synthetic polymers, autograft tissue, homograft tissue, xenografttissue, or one or more other suitable materials. In some embodiments,the valve structure 34 can be formed, for example, from bovine, porcine,equine, ovine and/or other suitable animal tissues. In some embodiments,the valve structure 34 can be formed, for example, from heart valvetissue, pericardium, and/or other suitable tissue. In some embodiments,the valve structure 34 can include or form one or more leaflets 36. Forexample, the valve structure 34 can be in the form of a tri-leafletbovine pericardium valve, a bi-leaflet valve, or another suitable valve.In some constructions, the valve structure 34 can comprise two or threeleaflets that are fastened together at enlarged lateral end regions toform commissural joints, with the unattached edges forming coaptationedges of the valve structure 34. The leaflets 36 can be fastened to askirt that in turn is attached to the frame 32. The upper ends of thecommissure points can define an inflow portion 38 corresponding to afirst or inflow end 40 of the prosthesis 30. The opposite end of thevalve can define an outflow portion 42 corresponding to a second oroutflow end 44 of the prosthesis 30. As shown, the stent frame 32 canhave a lattice or cell-like structure, and optionally forms or providescrowns 46 and/or eyelets 48 (or other shapes) at the outflow and inflowends 40, 44.

With the one exemplary construction of FIGS. 1A and 1B, the prostheticheart valve 30 can be configured (e.g., sized and shaped) for replacingor repairing an aortic valve. Alternatively, other shapes are alsoenvisioned, adapted to mimic the specific anatomy of the valve to berepaired (e.g., stented prosthetic heart valves useful with the presentdisclosure can alternatively be shaped and/or sized for replacing anative mitral, pulmonic or tricuspid valve). For example, FIG. 2illustrates another non-limiting example of a stent frame 50 portion ofanother prosthetic heart valve with which the systems, devices andmethods of the present disclosure are useful. In the normal or expandedcondition of FIG. 2, the stent frame 50 can be sized and shaped formitral valve implantation. Though not shown, the valve structureattached to the stent frame 50 defines an outflow portion 52 arranged ata first or outflow end 54, and an inflow portion 56 arranged at a secondor inflow end 58. As compared to the stent frame 32 of FIG. 1A, theinflow portion 56 can exhibit a more pronounced change in shape relativeto the corresponding outflow portion 52. Regardless, the stent frame 50can be forced and constrained to a compressed or collapsed condition(not shown, but akin to the shape of FIG. 1A) during delivery, and willself-expand to the natural or expanded condition of FIG. 2 upon removalof the constraining force(s). As reflected in FIG. 2, crowns 60 and/oreyelets 62 (or other shapes) optionally can be formed at one or both ofthe outflow and inflow ends 54, 58. Further, the stent frame 50 canoptionally include or carry additional structural components, such assupport arm(s) 64.

With the above understanding of stented prosthetic heart valves in mind,one embodiment of a delivery device 70 for percutaneously delivering theprosthesis is shown in simplified form in FIG. 3. The delivery device 70includes a delivery sheath assembly 72, an inner shaft assembly 74, anda handle assembly 76. A balloon 78 is also provided, and can optionallybe viewed as a component of the delivery device 70 at various stages ofuse of the delivery device 70. Details on the various components areprovided below. In general terms, however, the delivery device 70 andballoon 78 combine with a stented prosthetic heart valve (not shown) toform a system for performing a therapeutic procedure on a defectiveheart valve of a patient, such as repairing a defective heart valve. Thedelivery device 70 provides a loaded or delivery state in which astented prosthetic heart valve is loaded over the inner shaft assembly74 and is compressively retained within a capsule 80 of the deliverysheath assembly 72. For example, the inner shaft assembly 74 can includeor provide a valve retainer 82 configured to selectively receive acorresponding feature (e.g., posts) provided with the prosthetic heartvalve stent frame. The delivery sheath assembly 72 can be manipulated towithdraw the capsule 80 proximally from over the prosthetic heart valvevia operation of the handle assembly 76, permitting the prosthesis toself-expand and partially release from the inner shaft assembly 74. Whenthe capsule 80 is retracted proximally beyond the valve retainer 82, thestented prosthetic heart valve can completely release or deploy from thedelivery device 70. The delivery device 70 can optionally include othercomponents that assist or facilitate or control complete deployment.Regardless, the balloon 78 is disposed radially between the capsule 80and the prosthetic heart valve in the delivery state. As describedbelow, the balloon 78 is operable to control self-expansion or releaseof the prosthetic heart valve. In some embodiments, the balloon 78 isseparable from a remainder of the delivery device 70, and can be left inplace at a target native valve anatomy. In other embodiments, theballoon 78 is retracted from the patient with a remainder of thedelivery device 70 following implantation of the prosthetic heart valve.

Various features of the components 72-76 reflected in FIG. 3 and asdescribed below can be modified or replaced with differing structuresand/or mechanisms. Thus, the present disclosure is in no way limited tothe delivery sheath assembly 72, the inner shaft assembly 74, or thehandle assembly 76 as shown and described below. Any construction thatgenerally facilitates compressed loading of a stented prosthetic heartvalve over an inner shaft via a retractable outer sheath or capsule isacceptable. Further, the delivery device 70 can optionally includeadditional components or features, such as a flush port assembly 90, arecapture sheath (not shown), etc.

In some embodiments, the delivery sheath assembly 72 defines proximaland distal ends 100, 102, and includes the capsule 80 and an outer shaft104. The delivery sheath assembly 72 can be akin to a catheter, defininga lumen 106 (referenced generally) that extends from the distal end 102through the capsule 80 and at least a portion of the outer shaft 104.The lumen 106 can be open at the proximal end 100 (e.g., the outer shaft104 can be a tube). The capsule 80 extends distally from the outer shaft104, and in some embodiments has a more stiffened construction (ascompared to a stiffness of the outer shaft 104) that exhibits sufficientradial or circumferential rigidity to overtly resist the expectedexpansive forces of the stented prosthetic heart valve (not shown) whencompressed within the capsule 80. For example, the outer shaft 104 canbe a polymer tube embedded with a metal braiding, whereas the capsule 80includes a laser-cut metal tube that is optionally embedded within apolymer covering. Alternatively, the capsule 80 and the outer shaft 104can have a more uniform or even homogenous construction (e.g., acontinuous polymer tube). Regardless, the capsule 80 is constructed tocompressively retain the stented prosthetic heart valve at apredetermined diameter when loaded within the capsule 80, and the outershaft 104 serves to connect the capsule 80 with the handle assembly 76.The outer shaft 104 (as well as the capsule 80) is constructed to besufficiently flexible for passage through a patient's vasculature, yetexhibits sufficient longitudinal rigidity to effectuate desired axialmovement of the capsule 80. In other words, proximal retraction of theouter shaft 104 is directly transferred to the capsule 80 and causes acorresponding proximal retraction of the capsule 80. In otherembodiments, the outer shaft 104 is further configured to transmit arotational force or movement onto the capsule 80.

The inner shaft assembly 74 can have various constructions appropriatefor supporting a stented prosthetic heart valve within the capsule 80.The inner shaft assembly 74 can form or define at least one lumen (notshown) sized, for example, to slidably receive a guide wire (not shown).In some embodiments, the inner shaft assembly 74 includes anintermediate shaft or tube 110, a proximal shaft or tube 112 and aretention sub-assembly 114. The intermediate tube 110 is optionallyformed of a flexible polymer material (e.g., PEEK), and is sized to beslidably received within the delivery sheath assembly 72. The proximaltube 112 can include, in some embodiments, a leading portion 118 and atrailing portion 119. The leading portion 118 serves as a transitionbetween the intermediate and proximal tubes 110, 112, and in someembodiments is a flexible polymer tubing having a diameter slightly lessthan that of the intermediate tube 110. The trailing portion 119 canhave a more rigid construction, configured for robust assembly with thehandle assembly 76, such as a metal hypotube. Other constructions arealso envisioned. For example, in other embodiments, the intermediate andproximal tubes 110, 112 are integrally formed as a single, homogenoustube or solid shaft.

The retention sub-assembly 114 includes the valve retainer 82, an innersupport shaft 120 and a tip 122. The inner support shaft 120 is sized tobe slidably received within the lumen 106 of the delivery sheathassembly 72, and is configured for mounting to the intermediate tube 112(either directly or via the valve retainer 82). The inner support shaft120 can be a flexible polymer tube embedded with a metal braid. Otherconstructions are also acceptable so long as the inner support shaft 120exhibits sufficient structural integrity to support a loaded, compressedstented prosthetic heart valve (not shown). The tip 122 forms or definesa nose cone having a distally tapering outer surface adapted to promoteatraumatic contact with bodily tissue. The tip 122 can be fixed orslidable relative to the inner support shaft 120.

The handle assembly 76 generally includes a housing 140 and one or moreactuator mechanisms 142 (referenced generally). The housing 140maintains the actuator mechanism(s) 142, with the handle assembly 76configured to facilitate sliding movement of the delivery sheathassembly 72 relative to other components (e.g., the inner shaft assembly74). The housing 140 can have any shape or size appropriate forconvenient handling by a user.

With the above general explanations of exemplary embodiments of thecomponents 72-76 in mind, one embodiment of the balloon 78 is shown inFIGS. 4A and 4B. The balloon 78 is toroid-shaped or hollow, defining acentral passage 150 generally sized and shaped for receiving aprosthetic heart valve (not shown). As best shown in FIG. 4B, a materialof the balloon 78 can be wrapped on to itself to effectively provideinner and outer walls 152, 154 that generate the toroid shape. Thecentral passage 150 is circumscribed by the inner wall 152. An inflationchamber 156 is defined between the walls 152, 154. The central passage150 is open at opposing, first and second ends 160, 162 of the balloon78. The inflation chamber 156 is closed at the end 160, 162 such that aninflation medium (not shown) forced into the inflation chamber 156(e.g., via a port 164) causes the balloon 78 to expand. In someembodiments, the balloon 78 is configured (e.g., materials, shape setproperties, etc.) such that expansion occurs primarily in the radialdirection. The balloon 78 can be formed from any conventional,surgically safe material such as polyurethane, Nylon 12, polyethyleneterephthalate, Pebax, materials conventionally used with angioplastyballoons, etc.

In some embodiments, the balloon 78 is sized and shaped in accordancewith a size and shape of the prosthetic heart valve in question. Forexample, FIG. 5A illustrates in the balloon 78 assembled over aprosthetic heart valve 170, with the prosthetic heart valve 170 in thenormal or expanded condition. For ease of illustration, only the stentframe 172 of the prosthetic heart valve 170 is shown. Commensurate withthe descriptions above, the prosthetic heart valve 170 is disposedwithin the central passage 150 of the balloon 78. In some embodiments, alength of the balloon 78 is greater than a length of the prostheticheart valve 170 in the normal or expanded condition, with the balloon 78extending beyond one or both of the inflow and outflow ends 174, 176 ofthe prosthetic heart valve 170. The balloon 78 can be attached to theprosthetic heart valve 170 in some embodiments (e.g., the balloon 78 canbe bonded to an ePTFE skirt commonly provided with prosthetic heartvalves); with these and other embodiments, the balloon 78 can beconsidered a component of the prosthetic heart valve 170. Regardless,resiliency and other properties of the balloon 78 are optionallyselected such that the balloon 78 will stretch, fold or otherwise complywith a shape of the prosthetic heart valve 170 when forced to thecompressed or crimped condition as in FIG. 5B. As shown, a length of theballoon 78 can be greater than a length of the prosthetic heart valve170 in the compressed condition. Further, resiliency and otherproperties of the balloon 78 are such that the balloon 78 can beinflated (e.g., pressure or an inflation medium (e.g., gas or liquid) isgenerated in the inflation chamber 156), whereby the balloon 78experiences radial expansion as in FIG. 5C.

A simplified representation of a portion of a system 200 in accordancewith principles of the present disclosure, and including the deliverydevice 70 and the prosthetic heart valve 170 (including the balloon 78attached thereto) as described above, is provided in FIG. 6. In thedelivery state of FIG. 6, the prosthetic heart valve 170 is loaded andmaintained in a collapsed or crimped condition over the inner shaftassembly 74 by the capsule 80. The stent frame 172 is releasablyconnected to the valve retainer 82. The balloon 78 is in a deflatedarrangement and is disposed over the prosthetic heart valve 170,radially between the stent frame 172 and the capsule 80. That is to say,the deflated balloon 78 is exteriorly located relative to the stentframe 172. The capsule 80 is longitudinally moveable or slidablerelative to the balloon 78 and the prosthetic heart valve 170 (andvice-versa). A supply line 180 defining an inflation lumen (hidden) isfluidly connected to the inflation chamber 156 (hidden in FIG. 6, butshown, for example, in FIG. 4B) and extends proximally from the balloon78 to the handle assembly 76 (FIG. 3) for connection to a pressurizedinflation medium source (not shown) such as saline liquid, gas, etc. Forexample, the supply line 180 can be a tubular member attached to theport 164 (FIG. 4B) in a severable or detachable manner (e.g., frictionfit). In some embodiments, the delivery device 70 can further includeone or more mechanisms (e.g., a small guillotine-type device at a distalend of the supply line 180) that facilitate user-prompted severing ofthe supply line 180 from the balloon 78.

Use of the system 200 in providing a therapeutic treatment to adefective heart valve (e.g., repairing a defective heart valve) inaccordance with methods of the present disclosure can be described withreference to FIGS. 7A-7D. The system 200, in the delivery state, ismanipulated through a vasculature of the patient (e.g., via apercutaneous entry point in a femoral vein) to locate the prostheticheart valve 170 at a target site 210 of the patient's heart (or otheranatomical location) as in FIG. 7A. The target site 210 is depictedschematically in FIG. 7A and can be, for example, a mitral valve, aorticvalve, tricuspid valve, or pulmonary valve. With the system 200 nowlocated relative to the target site 210 as desired, the balloon 78 isincrementally pressurized (e.g., an inflation medium is forced into theinflation chamber 156 (FIG. 4B)) and the capsule 80 is incrementallyretracted. In some embodiments, the clinician or other user cansimultaneously control inflation of the balloon 78 and proximalretraction of the capsule 80 at the handle assembly 76 (FIG. 3).Regardless, with initial retraction of the capsule 80 and simultaneousinflation of the balloon 78, a region of the balloon 78 distal thedistal end 102 of the capsule 80 radially expands as depicted in FIG.7B. The capsule 80 as well as the supplied inflation pressure preventsthe region of the balloon 78 proximal the distal end 102 from radiallyexpanding. The exposed region of the balloon 78 expands into contactwith anatomy 212 (referenced generally) of the target site 210 (e.g.,walls of the patient's heart). Due to compliancy of the balloon 78, thecontacted anatomy 212 experiences minimal trauma. However, the contactedanatomy 212 resists the radially outward or expansive force of theinflating balloon 78, transferring those forces radially inwardly on tothe prosthetic heart valve 170. Thus, the inflating balloon 78 serves tomaintain the prosthetic heart valve 170 in the compressed or collapsedcondition. In other words, absent the inflating balloon 78, the regionof the prosthetic heart valve 170 distal the distal end 102 of thecapsule 80 would self-expand toward the normal or expanded condition;the expanded balloon 78 (in combination with the contacted anatomy)prevents the exposed region of the prosthetic heart valve 170 fromovertly self-expanding.

Incremental retraction of the capsule 80 and simultaneous, incrementalincreased pressure within the balloon 78 continues until the capsule 80is fully retracted from over the balloon 78 and the prosthetic heartvalve 170 as shown in FIG. 7C. In this intermediate deployment state,the balloon 78 remains connected to the supply line 180 and thus in aninflated arrangement. Further, the balloon 78 is in full contact withthe anatomy 212 (e.g., wall(s) of the heart) of the target site 210,positioned between the anatomy 212 and the stent frame 172 of theprosthetic heart valve 170. With this arrangement, the pressurizedballoon 78 maintains the prosthetic heart valve 170 in a collapsedcondition. The balloon 78 is then gradually deflated (i.e., theinflation medium within the inflation chamber 156 (FIG. 4B) is graduallywithdrawn via the supply line 180). As pressure within the balloon 78 islessened, resistance to the expansion force generated by the stent frame172 is removed, allowing the stent frame 172 to self-expand. A clinicianor other user is thus afforded the ability to control the expansion andrelease of the stent frame 172 to desired rate(s).

Once the balloon 78 is fully deflated, the prosthetic heart valve 170 isseated at the target site 210 due to the self-expanding construction ofthe stent frame 172 as in FIG. 7D. The balloon 78 is between the stentframe 172 and the anatomy 212 of the target site 210. In someembodiments, the supply line 180 is disconnected (e.g., severed) fromthe balloon 78, and a remainder of the delivery device 70 withdrawn fromthe patient. The balloon 78 thus remains in place, and is implanted withthe prosthetic heart valve 170. The so-situated balloon 78 canbeneficially provide a seal-like interface with the native anatomy 212,serving to minimize or prevent paravalvular leakage (PVL). In relatedembodiments in which a length of the balloon 78 is greater than a lengthof the stent frame 172, the balloon 78 can cover opposing ends or lipsof the stent frame 172 to protect, encompass and further prevent PVL. Inother embodiments, the balloon 78 can be retracted from the target site210 with a remainder of the delivery device 70.

Portions of another embodiment delivery device 300 useful with systemsand methods of the present disclosure are shown in FIG. 8. The deliverydevice 300 can be akin to the delivery device 70 (FIG. 3) describedabove, and generally includes a delivery sheath assembly 302, an innershaft assembly 304, a handle assembly (not shown, but akin to the handleassembly 76 (FIG. 3) described above) and a balloon 306. As withprevious embodiments, the delivery device 300 combines with a stentedprosthetic heart valve (not shown) to form a system for performing atherapeutic procedure on a defective heart valve of a patient, such asrepairing a defective heart valve. The delivery device 300 provides aloaded or delivery state in which a stented prosthetic heart valve isloaded over the inner shaft assembly 304 and is compressively retainedwithin a capsule 310 of the delivery sheath assembly 302. As a point ofreference, FIG. 8 depicts a deployment state of the delivery device 300(and thus of the corresponding system) in which the balloon 306 projectsdistally beyond a distal end 312 of the capsule 310; in a deliverystate, the balloon 306 is located within the capsule 310. In theillustrated embodiment, the balloon 306 is connected to the capsule 310as described in greater detail below. In other embodiments, the balloon306 can be separate from the capsule 310. Regardless, the balloon 306 isoperable to control self-expansion or release of the prosthetic heartvalve.

The inner shaft assembly 304 can be highly akin to the inner shaftassembly 74 (FIG. 3) described above, and can include a retentionsub-assembly 320 providing a valve retainer 322. Similarly, the balloon306 can be highly akin to the balloon 78 (FIG. 4B) described above,having a toroidal or hollow shape in extension between opposing, firstand second ends 330, 332. As with previous embodiments, the balloon 306defines a central passage 334 for receiving a prosthetic heart valve(not shown) and an inflation chamber 336.

The delivery sheath assembly 302 can be generally akin to the deliverysheath assembly 72 (FIG. 3) as described above, and includes the capsule310 terminating at the distal end 312. In some embodiments, the deliverysheath assembly 302 is configured to directly support the balloon 306and to provide a fluid connection or supply line to the inflationchamber 336. For example, the first end 330 of the balloon 306 can beconnected or attached to the distal end 312 of the capsule 310. In thedeployment state of FIG. 8, the balloon 306 is arranged to projectdistally beyond the distal end 312, with the second end 332 being distalthe first end 330. In a delivery state, and as generally reflected byFIGS. 9A and 9B (that otherwise omits the inner shaft assembly 304), theballoon 306 is deflated and tucked or inverted into the capsule 310,with the second end 332 now being proximal the first end 330.

With the above designations in mind, the capsule 310 can incorporate amulti-layer design. For example, the capsule 310 can include an outerlayer 340, an intermediate layer 342 and an inner layer 344. The outerlayer 340 can be formed of a polymer or similar material, and defines aninflation lumen (or supply line) 346. For example, the outer layer 340can be a surgically safe polymeric material molded to define the channel346. A proximal end (not shown) of the inflation lumen 346 can befluidly connected to source of pressure or inflation medium (not shown)as with previous embodiments. The intermediate layer 342 can be formedof a structurally robust material, selected to provide desired hoopstrength characteristics (e.g., sufficient to maintain a stentedprosthetic heart valve in a compressed condition). For example, theintermediate layer can be or include a metal, such as Nitinol™. In innerlayer 344 can be formed of a polymer or similar material selected tofacilitate a sliding interface with a prosthetic heart valve. Thus, theinner layer 344 can serve as an inner liner for the capsule. Otherconstructions having more or less of the layers 340-344 are alsoacceptable.

The first end 330 of the balloon 306 is attached (e.g., bonded) to thedistal end 312 of the capsule 310, with the lumen 346 being fluidly opento the inflation chamber 336. With this construction, pressure orinflation medium delivered to the inflation chamber 336 via the lumen346 causes the balloon 306 to “unfold” from the inverted arrangement ofFIGS. 9A and 9B to the deployment arrangement of FIG. 8 in which theballoon 306 extends distally beyond the distal end 312 of the capsule310. In other embodiments, the balloon 306 is not directly connected tothe capsule 310; a supply line apart from the capsule 310 is provided toassist in inflating the balloon 306 at a location distally beyond thecapsule 310. Regardless, when located outside of the capsule 310 andinflated, the balloon 306 radially expands.

In some embodiments, a length of the balloon 306 is less than a lengthof the prosthetic heart valve (not shown) to be deployed, optionally atleast one-half the length of the prosthetic heart valve. For example, aportion of a system 400 in accordance with principles of the presentdisclosure, and including the delivery device 300 and the prostheticheart valve 170 as described above, is provided in FIG. 10. In thedelivery state of FIG. 10, the prosthetic heart valve 170 is loaded andmaintained in a collapsed or crimped condition over the inner shaftassembly 304 by the capsule 310. The stent frame 172 is releasablyconnected to the valve retainer 322. The balloon 306 is in a deflatedarrangement and is disposed over the prosthetic heart valve 170,radially between the stent frame 172 and the capsule 310. That is tosay, the balloon 306 is inverted into the capsule 310, and is exteriorlylocated relative to the stent frame 172. As shown, a length of theballoon 306 is less than a length of the prosthetic heart valve 170; insome embodiments, the length of the balloon 306 is no greater than 25%of the length of the prosthetic heart valve 170. The capsule 310 islongitudinally moveable or slidable relative to the prosthetic heartvalve 170 (and vice-versa). In the illustrated embodiment, the balloon306 is attached to the capsule 310 and thus moves with movement of thecapsule 310. In other embodiments, the balloon 306 can be apart from thecapsule 310.

Use of the system 400 in providing a therapeutic treatment to adefective heart valve (e.g., repairing a defective heart valve) inaccordance with methods of the present disclosure can be described withreference to FIGS. 11A-11E. The system 400, in the delivery state, ismanipulated through a vasculature of the patient (e.g., via apercutaneous entry point in a femoral vein) to locate the prostheticheart valve 170 at a target site 410 of the patient's heart (or otheranatomical location) as in FIG. 11A. The target site 410 is depictedschematically in FIG. 11A and can be, for example, a mitral valve,aortic valve, tricuspid valve, or pulmonary valve. With the system 400now located relative to the target site 410 as desired, the balloon 306is incrementally pressurized (e.g., an inflation medium is forced intothe inflation chamber 346 (FIG. 8)) and the capsule 310 is incrementallyretracted. In some embodiments, the clinician or other user cansimultaneously control inflation of the balloon 306 and proximalretraction of the capsule 310 at the handle assembly (not shown, butakin to the handle assembly 76 in FIG. 3).

With initial retraction of the capsule 310 and simultaneous inflation ofthe balloon 306, the balloon 306 is caused to extend distally from thecapsule 310 and radially expand or inflate as depicted in FIG. 11B. Asection 420 of the prosthetic heart valve 170 is also exposed distal thedistal end 312 of the capsule 310 and begins to self-expand. The balloon306 is radially outside of and in contact with the exposed section 420,creating a funnel-like arrangement that slows or controls expansion ofthe exposed section 420. The balloon 306 thus creates a smoothertransition from the collapsed or crimped condition to the expandedcondition in the initial deployment state.

As the capsule 310 is further retracted, the balloon 306 is alsoretraced to retain the funnel effect at the deployment area of theprosthetic heart valve 170. For example, FIG. 11C illustrates a laterstage of deployment. As compared to the stage of FIG. 11B, in FIG. 11Cthe capsule 310 and the balloon 306 have been further retracted relativeto the prosthetic heart valve 170, such that an additional length of theprosthetic heart valve 170 is exposed and self-expands. The balloon 306remains in contact with an exposed section 422 of the prosthetic heartvalve 170 immediately distal the capsule distal end 312. Further, theballoon 306 (in the inflated arrangement) is in contact with anatomy 412(referenced generally) of the target site 410 (e.g., walls of thepatient's heart). Due to compliancy of the balloon 306, the contactedanatomy 412 experiences minimal trauma. However, the contacted anatomy412 resists the radially outward or expansive force of the inflatedballoon 306, transferring those forces radially inwardly on to theprosthetic heart valve 170. Thus, the balloon 306 serves to controlexpansion of the exposed section 422 akin to a funnel, serving as apillow between the exposed section 422 and the contacted anatomy 412.

Retraction of the capsule 310 and the balloon 306 relative to theprosthetic heart valve 170 continues to the stage of FIG. 11D in whichthe balloon 306 is at an end 174 of the prosthetic heart valve 170. Theballoon 306 is then deflated, as represented by FIG. 11E, allowing theend 174 to fully expand into engagement with the target site 410. Insome embodiments, the stent frame 172 includes or provides retentionmembers (not shown), such as paddles or arms, that can remain connectedto the delivery device 300 while the balloon 306 is deflated.Regardless, following deflation of the balloon 306, the prosthetic heartvalve 170 can be fully released from the delivery device 300. Thedelivery device 300, including the balloon 306, can then be removed fromthe patient.

The delivery devices, systems and methods of the present disclosureprovide a marked improvement over previous designs. By providing aninflated balloon between a self-expanding prosthetic heart valve and thenative anatomy, expansion of the prosthetic heart valve duringdeployment can be controlled.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure. For example, while the devices andsystems of the present disclosure have been described as being usefulfor delivering a stented prosthetic heart valve, a number of otherimplantable devices can be employed.

What is claimed is:
 1. A system for repairing a defective heart valve ofa patient, the system comprising: a delivery device including: an innershaft assembly, a delivery sheath assembly slidably disposed over theinner shaft assembly, the delivery sheath assembly including a capsuleterminating at a distal end; a balloon; and a prosthetic heart valveincluding a self-deploying stent carrying a prosthetic valve; whereinthe system is configured to provide: a delivery state in which thecapsule maintains the prosthetic heart valve in a collapsed conditionover the inner shaft assembly, and the balloon is in a deflatedarrangement radially between the prosthetic heart valve and the capsule,an initial deployment state in which at least a portion of the balloonand at least a portion of the prosthetic heart valve are located distalthe distal end, with the at least a portion of the balloon in aninflated arrangement and surrounding an exterior of the at least aportion of the prosthetic heart valve.
 2. The system of claim 1, whereinthe system is configured to further provide an intermediate deploymentstate in which: an entirety of the prosthetic heart valve is distallybeyond the distal end of the capsule; and the at least a portion of theballoon is in the inflated arrangement between the exterior of theprosthetic heart valve and an anatomy of a patient.
 3. The system ofclaim 2, wherein the system is configured to further provide: a deployedstate in which an entirety of the balloon and an entirety of theprosthetic heart valve are disconnected from the delivery device,including the balloon in the deflated arrangement and disposed betweenthe exterior of the prosthetic heart valve and an anatomy of a patient.4. The system of claim 2, wherein the system is configured to furtherprovide: a final deployment state in which an entirety of the prostheticheart valve and the at least a portion of the balloon are distal thedistal end, and the balloon is in the deflated arrangement and disposedbetween the exterior of the prosthetic heart valve and an anatomy of apatient.
 5. The system of claim 1, wherein the delivery device furtherincludes an inflation lumen fluidly connected to an interior of theballoon in at least the delivery state.
 6. The system of claim 5,wherein the inflation lumen is defined by a tubular body, and furtherwherein the delivery device further includes a severing mechanism fordisconnecting the tubular body from the balloon.
 7. The system of claim5, wherein the inflation lumen is defined, at least in part, by thecapsule.
 8. The system of claim 1, wherein a longitudinal length of theballoon is greater than a longitudinal length of the prosthetic heartvalve.
 9. The system of claim 1, wherein a longitudinal length of theballoon is less than a longitudinal length of the prosthetic heartvalve.
 10. The system of claim 1, wherein the balloon has a toroidshape.